Bharat Biotech's 'COVAXIN' gets approval for phase 3 trials in India

Covaxin, the coronavirus vaccine being developed by Bharat Biotech and ICMR, has received the approval by the Drugs Controller General of India (DCGI) to conduct the third phase of clinical trials.

The expert panel’s approval came after assessing data from Phases 1 and 2 along with animal trials. However, the committee suggested “minor amendments” in the protocol.

The study would cover 28,500 participants aged 18 years and above across 10 states. The Serum Institute of India began phase 3 clinical trial of Oxford vaccine last month.